Clinical performance evaluation of four automated chemiluminescence immunoassays for hepatitis C virus antibody detection.
Various automated chemiluminescence immunoassay (CLIA) analyzers for the detection of antibodies to hepatitis C virus (HCV) are now commercially available in clinical laboratories and are replacing conventional enzyme immunoassays. We investigated the performance of four anti-HCV CLIAs (the Architect Anti-HCV assay on the Architect i2000 system, the Vitros Anti-HCV assay on the Vitros ECiQ Immunodiagnostic System, the Access HCV Ab PLUS assay on the UniCel DxI 800 analyzer, and the newly developed Elecsys Anti-HCV assay on the Cobas e 411 analyzer). The total percent coefficient of variation values of imprecision were 3.5 to 5.7% with positive control materials and 7.2 to 10.2% with negative control materials. The agreement between the results of the Elecsys, Architect, Vitros, and Access CLIAs ranged from 94.5 to 98.1%. The clinical sensitivity of all CLIAs was 100%. Each CLIA showed excellent reproducibility and clinical sensitivity. The Elecsys, Architect, Vitros, and Access CLIAs showed clinical specificities of 98.2, 98.8, 96.5, and 98.2%.
Kim
Sinyoung
S
Department of Laboratory Medicine, Yonsei University College of Medicine, Seodaemun-gu, Seoul, Korea. kimhs54@yuhs.ac
Kim
Jeong-Ho
JH
Yoon
Seoyoung
S
Park
Youn-Hee
YH
Kim
Hyon-Suk
HS
D001331:Automation; D006526:Hepatitis C / Q000175:diagnosis*; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D049449:Luminescence; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D018937:Hepatitis C Antibodies